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Trauma Infant Neurological Score (TINS) as a Prognostic Factor and Guideline for CT Scan in Infants 24 Months Old or Less

NCT02731781 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2016-04-08

No results posted yet for this study

Summary

Traumatic brain injury (TBI) is the major cause of disability and death among the younger population. In the Pediatric population Head trauma may be responsible for primary and secondary brain damage. Primary brain injury results from a direct mechanical damage at the time of injury, whereas secondary injury is caused by further cellular damage that develops hours or days post injury. Intracranial Injury in Infants (III) may be hard to diagnose in the abcence of neurological deficit or early deterioration. On the other hand, symptoms such as vomiting and restlessness may be present even in the case of minor head injury, and unnesessary scaning (CT) may be performed in many centers just because clinical judgment is problematic in this particular age. Some intracranial injuries may be imminent, such as evolving Epidural hematoma (EDH) in infants, and early diagnosis may be lifesaving and leading to excellent outcome. In adults, GCS has been accepted as the most usuful tool for emergency evaluation of head injured patients. In children, several scores were introduced, including the Children's Coma Score (CCS), however they have been found problematic to use in the very young population, since accurate evaluation of communication in CCS is hard, and there is insufficient relevant parameters uncorporated into the score that may have significant importance in this particular age group. In TINS (Trauma Infant Neurological Score) we characterized the clinical parameters and the mechanism of trauma in a simplified method. As previously published, this score has been used by us and by other groups, in retrospective studies. Still, in the lack of prospective studies using TINS, there are no optimal guidelines to perform computed tomography (CT) in this unique population, and TINS has not prospectively been challenged as a predictor tool for outcome. In this prospective study we will approach these issues.

Conditions

  • TO FIND THE CORRELATION BETWEEN TINS SCORE OUTCOME

Interventions

OTHER

NONE . OBSERVATIONAL

OBSEVATION AND FOLLOW UP

Sponsors & Collaborators

  • Laniado Hospital

    lead OTHER

Eligibility

Min Age
24 Hours
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2018-10-31
Completion
2020-10-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02731781 on ClinicalTrials.gov